Two companies, c8 MediSensors and Dexcom, have received regulatory approvals for their Continuous Glucose Monitoring (CGM) systems in the EU and US respectively, though each company relies on very different technology to do its job of providing users access to real-time glucose levels.
San Jose, CA-based c8 MediSensors has received CE Mark approval for its Optical Glucose Monitor System, opening the door for distribution of the wearable sensor in the EU.
The device utilizes Raman spectroscopy, which involves a beam of light shone into the skin to scatter the glucose molecules, which generate a highly unique “fingerprint” that can be measured with a high degree of precision and distinguished from other substances in the body. The device communicates with a smartphone via Bluetooth and can be programmed to automatically send alerts when glucose levels move dangerously high or low.
According to c8’s press release (the first I have ever seen with 20 references) a definitive 10-year Diabetes Control and Complications Trial (DCCT) has demonstrated that individuals with type 1 diabetes who kept blood glucose levels as normal as possible for as long as possible had less chance of developing disease-related complications.
For example, the risk of eye disease reduced by 76 percent, kidney disease reduced by 50 percent, and nerve disease reduced by 60 percent. Other studies cited show CGM to have these same results related to reducing disease-related complications for type 2 diabetics as well.
“C8 MediSensors was co-founded by a father trying to help his son living with diabetes, and as a company, we remain dedicated to helping those with the disease,” said Paul Zygielbaum, CEO of C8 MediSensors. “CE Mark approval is a landmark step for this unique technology. Our team is hugely excited to be working to make nCGM and the Optical Glucose Monitor System available throughout Europe.”
The Dexcom device can also be programed to send users customized alerts about changes in glucose levels, and it has a built-in “Hypo-alert” generated for any indication that levels have strayed past 55 mg/dl.
“Improved accuracy in the critical hypoglycemic range is most important from a life-saving point of view,” said Terrance H. Gregg, DexcomCEO. “The Dexcom G4 PLATINUM fulfills the promise of CGM for people with diabetes by providing accurate and reliable real-time performance.”